摘要
目的 探索从卫生部层面采用卫生技术评估的高质量证据 ,对影响广、费用高、风险大、有争议的卫生技术实行准入管理的可行性。 方法 借鉴国外卫生技术评估与循证管理实践的经验 ,在国内建立了四家卫生技术评估和循证医学相关机构 ,推动和开展卫生技术评估工作。以“脐带血造血干细胞库”、“人类辅助生殖技术”、“人类精子库”等技术的管理问题为切入点 ,领导开展技术评估 ,以高质量证据制定卫生部的准入管理办法和条例。 结果 开展多项有关医疗设备、临床医疗技术、预防与疾病控制的筛查技术等方面研究与评估 ;制定了多个单项技术评估与循证准入管理办法 :《脐带血造血干细胞库管理办法》、《人类辅助生殖技术管理办法》、《人类精子库管理办法》等 ,指导各地机构和人员认证 ,规范管理。 结论 在我国建立卫生技术评估与循证准入管理制度已有一定基础 ,还需不断改进与完善 ,逐步形成行之有效的卫生技术准入管理运行机制。
Objective To investigate the feasibility of health technology permission (HTP) for widely used, high cost and risk technologies based on evidence of health technology assessment (HTA) from the perspective of Ministry of Health (MOH). Method With reference to experiences of HTA and evidence-based health administration in developed countries, four HTA and EBM entities have been established in China, which promoted and disseminated HTA. Three technologies - Bank of Haematopoietic Stem Cell from Umbilical Cord, Assisted Reproductive Technology(ART) and Sperm Bank - were piloted to assess, which provided quality evidence to assist MOH in formulating the Regulation for Permission on Health Technology. Results A set of technologies such as medical equipment, clinical techniques and screening technology for disease prevention and control have been assessed. Several regulations for permission on individual health technologies have been prepared to guide certification of professionals and health institutes. These include Regulation of Bank of Haematopoietic Stem Cell from Umbilical Cord, Regulation of Assisted Repreduction Technology and Management of Human Sperm Bank. Conclusions Although we have possessed a pre-requisite to establish a set of managing system for evidence-based permission of health technologies, an efficient infrastructure to run this system should be established and improved.
出处
《中国循证医学杂志》
CSCD
2004年第1期10-14,共5页
Chinese Journal of Evidence-based Medicine
关键词
中国
卫生技术
医药卫生
医疗保健
循证医学
Health technology
Health technology assessment
Health technology permission
